Results for “Senhance Surgical System”

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Registry EUDAMED 9 FDA 510(k) incl. De Novo 13 FDA PMA GUDID 7

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Germany 9

Risk class Class I Class IIa Class IIb 9 Class III Class II (US) 13

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TransEnterix Senhance Surgical System

Transenterix, Inc.,United States(FDA applicant)

Active Regimes: 510(k) Registry: 510(k) Class:II
Manipulator Arm

Asensus Surgical Italia S.r.l.,Italy

Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMED Class:IIb

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Results for “Senhance Surgical System”

Category (EMDN)

TransEnterix Senhance Surgical System

Manipulator Arm